Health TrialsbyHealthPanel

Anti-pigmenting Effect of a Routine of Facial Products in Subjects With Melasma

ConditionMelasma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorCosmetique Active International

About this trial

This 6 month, comparative study assesses the benefit of a dermocosmetic regimen (Serum B3 + B3 retinol night cream) for 6 months compared to hydroquinone 4% (the gold standard in hyperpigmentation) followed by the dermocosmetic regimen for 3 months or the Kligman Trio for 3 months followed by the dermocosmetic regimen for 3 months in adult women with melasma on the face.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18-65 years

Phototype II-V

50% with sensitive skin (declarative);

Subjects should be affected by well defined symmetrical (on both sides of the face) epidermal melasma (clinically diagnosed under Wood's light examination) lasting since more than a year

Disqualifiers

Subjects under topical or systemic retinoids;

Subjects having used topical tretinoin within 3 months or topical hydroquinone within 6 months prior to inclusion;

Subjects under systemic immunosuppressants and considered immune compromised

Subjects under active treatment of melasma (including topicals or procedures) within the last 3 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • Liftactiv® B3 Serum

    Other intervention

    In Group 1: Application once daily for 6 months, 3-4 drops twice a day (morning before the sunscreen and evening) In Group 2 and Group 3: Application once daily, 3-4 drops twice a day (morning before the sunscreen and evening) for 3 months following HQ4% or Kligman Trio treatment.

  • Liftactiv® B3 retinol night cream

    Other intervention

    In Group 1: Application once daily (morning) for 6 months In Group 2 and Group 3: During week 1, apply 2 evenings/week. During week 2, apply every other evening. During week 3, apply every evening. During nights when retinol night cream is not applied, replace with Mineral 89 cream for 3 months following HQ4% or Kligman Trio treatment.

  • Sunscreen UVAage® Inter SPF 50+

    Other intervention

    twice daily (morning and beginning of the afternoon)

  • Mineral 89 cream

    Other intervention

    2 drops in the morning before sunscreen application for 6 months

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Group 1Experimental treatment 4 interventions
Group B: Group 2Active comparator 4 interventions
Group C: Group 3Active comparator 4 interventions

Trial outcomes

Primary outcomes

1

antipigmenting assessment

Melasma Area Severity Index (MASI)

Time frame
Day 84
2

antipigmenting assessment

modified Melasma Area Severity Index (mMASI)

Time frame
Day 84
3

antipigmenting assessment

Melasma Area Severity Index(MASI)

Time frame
Day 168
4

antipigmenting assessment

modified Melasma Area Severity Index (mMASI)

Time frame
Day 168

Secondary outcomes

1

antipigmenting assessment

Melasma Area Severity Index(MASI)

Time frame
Day-28
2

antipigmenting assessment

modified Melasma Area Severity Index (mMASI)

Time frame
Day-28
3

antipigmenting assessment

Melasma Area Severity Index(MASI)

Time frame
baseline
4

antipigmenting assessment

modified Melasma Area Severity Index (mMASI)

Time frame
baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cosmetique Active International

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: